Last updated: 11/03/2018 23:48:34
PGx7660: Exploratory Pharmacogenetic Investigation of Efficacy Response to Relvar/Breo in Phase III COPD studies 112206, 112207, 113108, and 200820
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: PGx7660: Exploratory Pharmacogenetic Investigation of Efficacy Response to Relvar/Breo in Phase III COPD studies 112206, 112207, 113108, and 200820
Trial description: RELVAR/BREO® is a once-daily combination therapy for the long-term treatment of Chronic Obstructive Pulmonary Disease (COPD). The objective of this study is to identify genetic variants influencing efficacy response in COPD subjects enrolled in four clinical studies who were treated with RELVAR/BREO. Candidate genetic variants with previous evidence of effects on COPD and related traits or on response to COPD treatments will be prioritized into a separate tier to test for association. All other genome-wide variants, measured or imputed, will be tested for association with key efficacy endpoints. Linear regression of the efficacy endpoints will be conducted to test for a main effect for each genetic variant in pooled data at the subject level across five studies HZC112206, HZC112207, HZC113108, and 200820 adjusted for study as a categorical covariate. BREO and RELVAR are trademarks of the GlaxoSmithKline (GSK) Group of Companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on the last day at the end of the study specific treatment period
Timeframe: Study treatment period, i.e., treatment initiation to last dose - for Change from baseline trough FEV1. 24 weeks for HZC112206, HZC112207, and HZC113108 and 12 weeks for 200820
Secondary outcomes:
Not applicable
Interventions:
Drug: RELVAR/BREO
Enrollment:
1
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
July 2016 to July 2016
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
none
- Subjects who provided written informed consent and a DNA sample and had clinical outcome data available were included in the study.
- Subjects who did not provide written informed consent, a DNA sample, or did not have the clinical outcome data available were excluded from study.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who provided written informed consent and a DNA sample and had clinical outcome data available were included in the study.
Exclusion criteria:
- Subjects who did not provide written informed consent, a DNA sample, or did not have the clinical outcome data available were excluded from study.
Trial location(s)
No location data available.
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2016-29-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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